FDA.reportPublic FDA data

BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit

Primary DI
00382902560456
Brand
BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit
Company
BECTON, DICKINSON AND COMPANY
Model
256045
Catalog number
256045
Device description
Kit Flu A+B 30 Test Physician Veritor
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GNXANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
PSZDevices detecting influenza A, B, and C virus antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112277000
K132259000
K132692000
K151291000
K152870000
K160161000
K180438000
K223016000
K232434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112277000BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2011-10-28PSZ
K132259000BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2013-08-07PSZ
K132692000BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2013-09-23PSZ
K151291000BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company2015-06-10PSZ
K152870000BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co.2015-10-27PSZ
K160161000BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO2016-02-24PSZ
K180438000BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd2018-03-20PSZ
K223016000BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd2023-01-27PSZ
K232434000BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd2023-12-05PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902560456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902560456003829025604563829025604560382902560456

GMDN Terms#

Term, Definition table
TermDefinition
Influenza/parainfluenza virus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from influenza and parainfluenza viruses [e.g., influenza A, influenza B, human parainfluenza virus 1 (HPIV-1), human parainfluenza virus 2 (HPIV-2)] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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